For over a decade, truncal varicose veins have most commonly been treated using minimally invasive techniques, such as endolasers, radiofrequency and echo guided sclerotherapy with microfoam drugs, thus leaving purely surgical techniques (stripping) for extremely developed cases.
These techniques continue to prevail, since they achieve the same or even better results than traditional treatments, and can be carried out at outpatient clinics. The Endovenous Laser Treatment (EVLT) method, also known as the endolaser technique, is currently one of the most commonly employed techniques, given that it is safe, effective and offers quick recovery. As is already known, it consists in introducing a thin optical laser fiber into the inside of the vein to be treated, thus removing and sealing off the damaged vein upon applying the energy needed and giving rise to subsequent healing.
Sclerosant medication is also injected intravenously in liquid form and/or as foam, in order to irritate the venous endothelium. The microfoam variety that contains less product furthermore produces a greater effect in terms of obliterating treated areas.
All other techniques, such as radiofrequency, the administration of water vapor at high temperatures and the application of sealant substances inside truncal varicose veins, seek the same outcome, i.e. to remove, seal and subsequently heal the vein and/or veins treated, in order to eliminate the condition.
Indeed, many registrations have been made within this field, which only use laser devices. Of these registrations, U.S. Pat. No. 6,398,777 by ENDOLASER ASSOCIATES LLC stands out, defining another, different device for treating varicose veins by emitting laser radiation through a fiber optic cable and an angiocatheter, the effect of which is produced through contact with the venous endothelium, but which is nevertheless different from the present invention in that it does not facilitate the administration of medication, since it requires much more energy. Indeed, the new invention reduces said energy by 90%. Moreover, the current patent facilitates or blocks contact with the inner wall of the vein, whilst the prior patent requires contact in all cases. Patent WO2006/052558 by COOLTOUCH INC, also stands out, since it develops a fiber optic device for treating varicose veins using an infrared laser, which defines an opening in the distal end thereof and defines a wave interval for correct usage. Patent US 2006/0189967 by MASOTTI LEONARDO also stands out, since it develops another device for treating varicose veins using laser radiation, specifically using a Holmium laser. Meanwhile, U.S. Pat. No. 5,053,033 by CLARKE stands out, since it also uses fiber optic technology, although the same is used to keep the blood vessel open and is of little use when it comes to treating varicose veins. Patent US2009/0264875 by WILLIAM M. APPLING stands out since it defines a laser device for treating varicose veins using an expandable separator located at its distal end, which enables the heat energy of the laser to be better distributed at said end. Meanwhile, U.S. Pat. No. 5,531,739 by TRELLES stands out, since it also uses a fiber optic probe to reach the underneath of the blood vessel to be treated, this methodology being completely different to that used as an object of the present invention. Patent US 2008071333 by HAYES CLINT stands out, since it develops another laser device with which to treat varicose vein conditions, by means of eliminating venous reflux in an underlying vein, introducing a catheter and emitting energy by means of a laser. Examples of registrations comprising a surgical method, such as patent EP311295 must also be highlighted, this patent making a piece of surgical apparatus comprising a waveguide of the fiber optic variety, for example, known, through which laser energy is applied. EP0152766 is furthermore noteworthy within the background art, since it reveals a piece of apparatus for reducing these problems by selectively using electromagnetic energy, whilst patent ES2132028 by Dr. CARLOS BONE—the same inventor as he who designed the present patent—must be highlighted, since it defines an endoluminal electro-coagulator for varicose vein operations, the same constituting a surgical instrument consisting of an electro-coagulating head-piece, joined to a flexible conductor wire. Likewise, patent ES2188398, also by Dr. CARLOS BONE, stands out, upon defining a piece of pocket laser apparatus, whilst patent WO2013081768 by VASCULAR SOLUTIONS is noteworthy, with an expandable, extendible device for the occlusion of varicose veins. Patent WO2010135793 by EDUARDO SISTEROLLI must be mentioned within the background literature, upon defining a radiofrequency treatment, whilst patents that develop a methodology consisting in the injection of an sclerosant substance, such as WO2009100435 by RICHARD W. BOCK, which defines the intravenous injection of a sclerosant with a certain composition and patent JP20060216894 by JMS Co, which also defines a medical fluid connector that enables different fluids and gasses to be mixed in order to create a foam for the treatment of varicose veins, should also be acknowledged, although the latter does not have just one opening in its distal portion. Similarly, patent EP1377328 by PENTAFERTE SPA should be taken into consideration, since it defines a foam injection device designed to treat varicose veins, which resembles a syringe. Finally, patent EP2269578 by BTG INTERNATIONAL deserves background recognition, upon defining a device designed to introduce microfoams, which defines a tube diameter and the generation of said foam with characteristics specific to said device.
Patent EP2596759 by TECHLAMED SRL must also be highlighted, since it defines a method for treating varicose veins, whereby the varicose vein is firstly treated using a laser, before a sclerosant treatment is subsequently applied in the form of foam. Nevertheless, this patent differs from that of the present application in many different ways, for example, in that it does not permit the two treatments to be carried out synergistically, in synchronization and in that it refers to firstly introducing the laser through the catheter, emitting the energy, removing the laser and subsequently injecting the sclerosant substance once the laser has been removed, finally taking the catheter or tube out, thus demonstrating that it is by no means synchronized, in addition to requiring much greater power flows than those required by the invention object of the present patent, all the while using instruments known about on the market, without this instrumentation introducing any kind of novelty whatsoever. As will become evident throughout this description, not only will the present invention better and improve upon this instrumentation, but rather upon the methodology as well, given that the new patent gives rise to the simultaneous chemical and thermal removal of varicose veins, thus reinforcing the effects of both treatment aspects, making it possible to reduce energy concentration and the amount of medication administered, whilst increasing efficacy and making it possible to work without local anesthetic, be it tumescent, perivenous and/or truncal.
The use of the above techniques for treating truncal varicose veins, which, little by little, have become less invasive, constitutes a major advancement in the treatment of the same, in converting a purely surgical treatment into a less aggressive treatment, which can be carried out fully at outpatient centers. All of the above techniques seem to be effective when carried out by expert hands. Indeed, the results obtained using the endolaser technique have proven to be highly effective, despite requiring local anesthetic to be introduced in various different ways, including in a perivenous, tumescent and truncal manner, in order for this practice to be carried out, given that the energy released inside the vein, which comes into contact with the vascular endothelium, gives rise to heat removal, thus requiring analgesic-anesthetic in order to proceed correctly.
However, the new device object of the present invention has made it possible to develop a new method, by means of synthesizing two techniques, which does not require local anesthetic in order to successfully irritate the venous endothelium and consequently remove truncal varicose veins, it thereby being possible to practice this method during medical consultations using the pertinent asepsis measures, without the need for a strict surgical environment. There are no diameter limits for venous confluences or for the path thereof. In fact, it is possible to confirm immediate response one hundred percent reliably by means of echography. This immediate response is achieved by no more than 8 to 10 cc of sclerosant microfoam, at 1.5 to 2%, which is administered and controlled by means of echography, thus enabling us to complement treatment synergistically by means of the heat action of the laser, with a minimal energy dose, thereby eliminating the need to use anesthetic and making it possible to carry this technique out at outpatient clinics alone.